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Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma

NCT06124976 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-15

No results posted yet for this study

Summary

The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat Upper Tract Urothelial Carcinoma (UTUC) in participants who have a low-grade tumor.

The main questions this study aims to answer are:

1. Can ST-02 effectively eradicate UTUC by 3 months?
2. Is ST-02 safe for patients with UTUC?

Participants in this study will receive ST-02, a new formulation with gemcitabine once weekly for six weeks. Gemcitabine is known to be an effective drug in treating urothelial carcinoma. This new formulation will be instilled directly into the upper urinary tract (renal pelvis) and will allow the chemotherapeutic to work locally for an extended period of time. The administration process will be retrograde (via a small catheter inserted up into the kidney, under anesthesia) or antegrade (via a nephrostomy, in the clinic) once weekly for six weeks. Safety and efficacy will be monitored for up to a year after the initial response assessment.

Conditions

  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Transitional Cell Cancer of the Renal Pelvis and Ureter

Interventions

DRUG

ST-02

ST-02 drug instillation into the upper urinary tract (renal pelvis)

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Peter Black, Dr. · Vancouver Prostate Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-19
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124976 on ClinicalTrials.gov